▲JNPMEDI Kyoungju Oh Senior Consultant, Kiwon Yoon Consultant
Why CDISC Matters: The Case for Standardization
In clinical trials—the core of new drug development—the ways data are collected, managed, and analyzed vary widely across pharmaceutical companies and contract research organizations (CROs). As a result, multiple formats and terminologies coexist, creating major interoperability challenges. This lack of standardization complicates data submission and review processes at regulatory agencies and is one of the leading causes of delayed approvals. It is akin to attempting communication in a mix of Korean, English, and French with no interpreter. Converting such disparate “languages” into a unified format requires significant time and cost, ultimately reducing the overall efficiency of drug development.
The Emergence and Role of CDISC
To address the problem of non-standardized clinical data, the Clinical Data Interchange Standards Consortium (CDISC) was established in 1997 as an international nonprofit organization dedicated to developing and promoting global standards for clinical trial data. Applying CDISC standards ensures that all clinical trial data share the same structure and format, making integration and analysis far easier—even when multiple organizations are involved. CDISC effectively serves as a global “interpreter,” unifying data into one common language and dramatically improving accessibility, interoperability, and reusability.
As major global regulatory authorities increasingly mandate data standardization, CDISC’s role has become essential. The U.S. Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and China’s National Medical Products Administration (NMPA) all require data submissions aligned with CDISC standards—a trend that continues to expand worldwide. As a result, CDISC is no longer simply a data-organization tool; it has become a fundamental requirement for obtaining international drug approvals. By maximizing the value of clinical data and improving operational efficiency, CDISC serves as a key solution for accelerating the delivery of new therapies to patients.
Why CDISC Is Strongly Recommended: Enabling One Unified Language
Why, then, is CDISC so strongly recommended? Because clinical trials involve multiple sites, disciplines, and systems. Without standards, each party uses its own formats and terminology, leading to endless data mapping, cleaning, and re-verification. This drastically undermines development efficiency.
When CDISC standards are applied consistently from data collection through analysis and submission, data structure and meaning remain aligned. Error rates decrease, reproducibility increases, and traceability improves. Standardized formats also help regulators automate and streamline reviews, enabling faster decision-making.
For instance, different institutions may record gender as “남/여,” “Male/Female,” “M/F,” or mixed Korean/English notations. Lab units may appear as “mg/dL” in one dataset and “mmol/L” in another. CDISC consolidates such inconsistencies into one harmonized format, ensuring data integrity, traceability, and consistent interpretation—even during audits or re-analysis.
Key CDISC Standards
CDISC provides multiple standards, among which SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) are the most prominent.
- SDTM standardizes and structures collected (raw) data into a “submission-ready” format. It links to validation rules that enable automated quality checks prior to submission.
- ADaM organizes standardized datasets into analysis-ready structures so statisticians can easily identify the variables required for statistical evaluation, improving efficiency and reproducibility.
CDISC also provides:
- CDASH(Clinical Data Acquisition Standards Harmonization), which aligns case report forms (CRFs) with SDTM terminology from the moment of data entry.
- SEND(Standard for Exchange of Nonclinical Data), which standardizes nonclinical data for use in regulatory submissions.
Together, these standards maintain consistency and quality across the entire clinical trial lifecycle. Ultimately, CDISC operates as the most reliable pathway toward establishing a “common language” for clinical data and accelerating regulatory decision-making.
Benefits of Using CDISC Standards
Standardizing clinical data through CDISC provides several advantages:
- Fostered efficiency: Reduces redundancy and streamlines workflows across data collection, management, and analysis.
- Complete traceability: Ensures each data point can be traced from initial capture through final submission.
- Enhanced innovation: Enables faster research and discovery through structured datasets.
- Increased predictability: Improves consistency in interpretation and analysis, enhancing the reliability of trial outcomes.
- Improved data quality: Reduces errors and elevates the overall quality of collected data.
- Facilitated data sharing: Simplifies integration among pharmaceutical companies, CROs, hospitals, and global agencies.
- Streamlined processes and reduced costs: Cuts time spent on data cleaning and transformation, increasing speed and lowering overall development costs.
Global Adoption of CDISC and Korea’s Next Steps
Globally, regulators increasingly require or strongly recommend that clinical trial data be submitted in the “CDISC language.” This requirement goes beyond documentation preferences—it’s a coordinated effort to enhance data interoperability and accuracy on a global scale.
The FDA mandated CDISC standards in 2017, followed by PMDA in Japan and NMPA in China. EMA-authorized submissions also widely follow CDISC standards. CDISC has therefore become a global requirement rather than an optional enhancement.
Korea’s Clinical Trial Strength and the Need for CDISC
Korea is recognized as a global leader in clinical trials.
According to the Ministry of Food and Drug Safety (MFDS), Korea ranked **6th worldwide in 2024** for overall clinical trial activity—following the U.S., China, Australia, Spain, and Germany. Seoul ranked **second globally** among cities hosting pharmaceutical-sponsored clinical trials.
Korea has maintained top-tier performance since 2020 and is firmly established as a global clinical trial hub. To sustain and strengthen this position, adopting CDISC is essential. For Korean pharmaceutical companies targeting global markets, CDISC provides a competitive advantage by reducing review timelines and improving submission efficiency.
MFDS Progress and Future Directions
Recognizing these global trends, Korea’s MFDS has begun aligning its regulatory framework with CDISC requirements.
In April 2021, MFDS revised approval regulations to allow CDISC-formatted submissions for clinical and nonclinical datasets. In 2023, it established a CDISC expert committee to initiate broader integration.
However, more progress is needed. CDISC is not simply a technical specification—it is a foundational accelerator that standardizes clinical trial design, data collection, analysis, and submission. Korea must regard CDISC not as a procedural formality but as an essential “entry visa” for global regulatory pathways and a core infrastructure for future clinical development.
To achieve this, government authorities, pharmaceutical companies, and CROs must collaborate to expand CDISC training, strengthen workforce capabilities, and build the technical infrastructure required for standardization. Effective adoption of CDISC will help Korea maintain its competitive edge in the global clinical trial landscape and accelerate new drug development.
▲JNPMEDI Kyoungju Oh Senior Consultant, Kiwon Yoon Consultant
Why CDISC Matters: The Case for Standardization
In clinical trials—the core of new drug development—the ways data are collected, managed, and analyzed vary widely across pharmaceutical companies and contract research organizations (CROs). As a result, multiple formats and terminologies coexist, creating major interoperability challenges. This lack of standardization complicates data submission and review processes at regulatory agencies and is one of the leading causes of delayed approvals. It is akin to attempting communication in a mix of Korean, English, and French with no interpreter. Converting such disparate “languages” into a unified format requires significant time and cost, ultimately reducing the overall efficiency of drug development.
The Emergence and Role of CDISC
To address the problem of non-standardized clinical data, the Clinical Data Interchange Standards Consortium (CDISC) was established in 1997 as an international nonprofit organization dedicated to developing and promoting global standards for clinical trial data. Applying CDISC standards ensures that all clinical trial data share the same structure and format, making integration and analysis far easier—even when multiple organizations are involved. CDISC effectively serves as a global “interpreter,” unifying data into one common language and dramatically improving accessibility, interoperability, and reusability.
As major global regulatory authorities increasingly mandate data standardization, CDISC’s role has become essential. The U.S. Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and China’s National Medical Products Administration (NMPA) all require data submissions aligned with CDISC standards—a trend that continues to expand worldwide. As a result, CDISC is no longer simply a data-organization tool; it has become a fundamental requirement for obtaining international drug approvals. By maximizing the value of clinical data and improving operational efficiency, CDISC serves as a key solution for accelerating the delivery of new therapies to patients.
Why CDISC Is Strongly Recommended: Enabling One Unified Language
Why, then, is CDISC so strongly recommended? Because clinical trials involve multiple sites, disciplines, and systems. Without standards, each party uses its own formats and terminology, leading to endless data mapping, cleaning, and re-verification. This drastically undermines development efficiency.
When CDISC standards are applied consistently from data collection through analysis and submission, data structure and meaning remain aligned. Error rates decrease, reproducibility increases, and traceability improves. Standardized formats also help regulators automate and streamline reviews, enabling faster decision-making.
For instance, different institutions may record gender as “남/여,” “Male/Female,” “M/F,” or mixed Korean/English notations. Lab units may appear as “mg/dL” in one dataset and “mmol/L” in another. CDISC consolidates such inconsistencies into one harmonized format, ensuring data integrity, traceability, and consistent interpretation—even during audits or re-analysis.
Key CDISC Standards
CDISC provides multiple standards, among which SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) are the most prominent.
- SDTM standardizes and structures collected (raw) data into a “submission-ready” format. It links to validation rules that enable automated quality checks prior to submission.
- ADaM organizes standardized datasets into analysis-ready structures so statisticians can easily identify the variables required for statistical evaluation, improving efficiency and reproducibility.
CDISC also provides:
- CDASH(Clinical Data Acquisition Standards Harmonization), which aligns case report forms (CRFs) with SDTM terminology from the moment of data entry.
- SEND(Standard for Exchange of Nonclinical Data), which standardizes nonclinical data for use in regulatory submissions.
Together, these standards maintain consistency and quality across the entire clinical trial lifecycle. Ultimately, CDISC operates as the most reliable pathway toward establishing a “common language” for clinical data and accelerating regulatory decision-making.
Benefits of Using CDISC Standards
Standardizing clinical data through CDISC provides several advantages:
- Fostered efficiency: Reduces redundancy and streamlines workflows across data collection, management, and analysis.
- Complete traceability: Ensures each data point can be traced from initial capture through final submission.
- Enhanced innovation: Enables faster research and discovery through structured datasets.
- Increased predictability: Improves consistency in interpretation and analysis, enhancing the reliability of trial outcomes.
- Improved data quality: Reduces errors and elevates the overall quality of collected data.
- Facilitated data sharing: Simplifies integration among pharmaceutical companies, CROs, hospitals, and global agencies.
- Streamlined processes and reduced costs: Cuts time spent on data cleaning and transformation, increasing speed and lowering overall development costs.
Global Adoption of CDISC and Korea’s Next Steps
Globally, regulators increasingly require or strongly recommend that clinical trial data be submitted in the “CDISC language.” This requirement goes beyond documentation preferences—it’s a coordinated effort to enhance data interoperability and accuracy on a global scale.
The FDA mandated CDISC standards in 2017, followed by PMDA in Japan and NMPA in China. EMA-authorized submissions also widely follow CDISC standards. CDISC has therefore become a global requirement rather than an optional enhancement.
Korea’s Clinical Trial Strength and the Need for CDISC
Korea is recognized as a global leader in clinical trials.
According to the Ministry of Food and Drug Safety (MFDS), Korea ranked **6th worldwide in 2024** for overall clinical trial activity—following the U.S., China, Australia, Spain, and Germany. Seoul ranked **second globally** among cities hosting pharmaceutical-sponsored clinical trials.
Korea has maintained top-tier performance since 2020 and is firmly established as a global clinical trial hub. To sustain and strengthen this position, adopting CDISC is essential. For Korean pharmaceutical companies targeting global markets, CDISC provides a competitive advantage by reducing review timelines and improving submission efficiency.
MFDS Progress and Future Directions
Recognizing these global trends, Korea’s MFDS has begun aligning its regulatory framework with CDISC requirements.
In April 2021, MFDS revised approval regulations to allow CDISC-formatted submissions for clinical and nonclinical datasets. In 2023, it established a CDISC expert committee to initiate broader integration.
However, more progress is needed. CDISC is not simply a technical specification—it is a foundational accelerator that standardizes clinical trial design, data collection, analysis, and submission. Korea must regard CDISC not as a procedural formality but as an essential “entry visa” for global regulatory pathways and a core infrastructure for future clinical development.
To achieve this, government authorities, pharmaceutical companies, and CROs must collaborate to expand CDISC training, strengthen workforce capabilities, and build the technical infrastructure required for standardization. Effective adoption of CDISC will help Korea maintain its competitive edge in the global clinical trial landscape and accelerate new drug development.